Immediate Transfusion in African Children with Uncomplicated Severe Anemia.
Immediate Transfusion in African Children with Uncomplicated Severe Anemia.
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DOI：
10.1056/nejmoa1900105
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发表时间：
2019-08-01
期刊：
影响因子：
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通讯作者：
TRACT Group
中科院分区：
文献类型：
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作者：
Maitland K;Kiguli S;Olupot-Olupot P;Engoru C;Mallewa M;Saramago Goncalves P;Opoka RO;Mpoya A;Alaroker F;Nteziyaremye J;Chagaluka G;Kennedy N;Nabawanuka E;Nakuya M;Namayanja C;Uyoga S;Kyeyune Byabazaire D;M'baya B;Wabwire B;Frost G;Bates I;Evans JA;Williams TN;George EC;Gibb DM;Walker AS;TRACT Group
世界卫生组织建议非洲住院的无并发症严重贫血（血红蛋白4-6克/分升）儿童不要输血。然而，高死亡率和再入院率表明，限制较少的输血策略可能会改善结果。该开放标签试验将2个月至12岁、血红蛋白为4-6g/dl且无严重症状的乌干达和马拉维儿童随机分配到立即输血20或30ml/kg全血当量（容量取决于第二次随机化）或不立即输血（对照组，随后因新的严重症状或血红蛋白<4g/dl而触发20ml/kg输血）。另外三个随机分组调查了输血血容量、出院后微量营养素和/或复方新诺明。主要终点为28天死亡率。1565名儿童（中位26个月；977名（62%）疟疾患者）随机分为立即输血组（n=778）或对照组（n=787），随访180天（71名（5%）失访）。入院期间，778名（100%）患儿接受了输血，对照组为386名（49%）患儿接受了输血（随机分组后中位数为1.3小时对24.9小时）。接受的平均（标准差）全血当量分别为314（228）毫升和142（224）毫升。输血组7例（1%）对对照组13例（2%）在28天前死亡（风险比[HR]=0.54 (95% CI 0.22-1.36) p=0.19），对照组35例（4%）对47例（6%）在180天前死亡（风险比[HR]= 0.75(0.48-1.15)），没有与其他随机分组相互作用的证据（p> .2），也没有再入院或严重不良事件的组间差异，也没有180天血红蛋白恢复的证据。对照组的住院时间平均延长了0.9天。在6个月以上的临床结果中，没有证据表明两组之间存在差异。触发性输血（对照组）减少了输血需求，但增加了住院时间，需要临床和反复监测血红蛋白。(由医学研究理事会和国际发展部（通过与MRC签订的协议）资助，资助号MR/JO 12483，联合王国；当前对照试验编号，ISRCTN84086586)
The World Health Organization recommends not transfusing African children hospitalized with uncomplicated severe anemia (hemoglobin 4-6g/dl). However, high mortality and readmission rates suggest less restrictive transfusion strategies might improve outcomes. The TRACT factorial open-label trial randomized Ugandan and Malawian children 2 months to 12 years with hemoglobin 4-6g/dl and no severity signs to immediate transfusion with 20 or 30ml/kg whole-blood equivalent (volume depending on second randomization) or no immediate transfusion (control, transfusion with 20ml/kg triggered subsequently by new severity signs or hemoglobin<4g/dl). Three other randomizations investigated transfusion blood volume, post-discharge micronutrients and-or cotrimoxazole. The primary endpoint was 28 day mortality. Fifteen-hundred-sixty-five children (median 26 months; 977(62%) with malaria) were randomized to immediate transfusion (n=778) or control (n=787) and followed for 180 days (71(5%) lost-to-follow-up). Seven-hundred-seventy-eight (100%) transfusion vs. 386(49%) control children were transfused during admission (median 1.3 vs. 24.9 hours from randomization). Mean (standard deviation) whole-blood equivalent received was 314(228) vs. 142(224) milliliters, respectively. Seven(1%) transfused vs. 13(2%) control children died before 28 days (hazard ratio[HR]=0.54 (95% CI 0.22-1.36) p=0.19), and 35(4%) vs. 47(6%), respectively, died before 180 days (HR=0.75 (0.48-1.15)), without evidence of interaction with other randomizations (p>0.2) nor evidence of between-group differences in readmissions or serious adverse events, nor hemoglobin recovery at 180 days. Length-of-stay was mean 0.9 days longer in the controls. There was no evidence of between-group differences in clinical outcomes over 6 months. Triggered transfusion (control group) reduced blood transfusion requirements but increased length-of-stay and required clinical and repeated hemoglobin monitoring. (Funded by the Medical Research Council and Department for International Development (through a concordat with MRC) Grant Number MR/JO 12483, United Kingdom; TRACT Current Controlled Trials number, ISRCTN84086586)